Coronary Artery DiseaseGUIDEX®_FRNCT06009757
GUIDEX® Versus Launcher™ Guiding Catheter in Percutaneous Coronary Intervention (PCI) (GUIDEX_FR)
A study testing GUIDEX® guiding catheter and Launcher™ coronary guide catheter in people with Coronary Artery Disease, run by Tianjin Demax Medical Technology Co., Ltd at 1 site in France.
Trial summary
The goal of this clinical trial is to compare two guiding catheters in patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- GUIDEX® guiding catheter and Launcher™ coronary guide catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2025to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients need to be at least 18 years old.
- Patients with significant coronary artery disease who qualify for PCI (according to ACC/AHA/SCAI 2021 guidelines, including that the patient has received medical therapy with exercise and dietary recommendations before or at the same time as the PCI decision and that the clinical decision depends on the cardiology team) and who can be treated with a radial and femoral approach
- Patients scheduled for for Percutaneous Coronary Intervention and must remain overnight for observation
- The target vessel must have a TIMI flow 3 at baseline
- Palpable radial or fermoral artery
- Patients covered by the social security system
Who cannot join
- Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography)
- Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- Prior PCI procedure within the last 30 days of the index procedure
- Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
- Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
- Target vessel < 2.4 mm in diameter
Show all 16Show fewer
- Target lesion > 32 mm in length
- Patient has allergy to imaging contrast media for which they cannot be pre-medicated
- Patients with hypersensitivity or contraindication to antiplatelet treatment
- Patient unable to stop his or her daily oral medication includes metformin treatment during 48 hours.
- Unstable patient: myocardial infarction, cardiogenic shock or with troponin above the upper limit of the normal laboratory value in the 24 hours prior to the procedure OR with elevated troponin and abnormal concomitant CK (non-exhaustive list).
- Unable to follow the requirements of the protocol.
- Vulnerable: whose ability or freedom to give or refuse consent is limited.
- Patients who cannot read or write french;
- Major protected by law (tutorship, curatorship, safeguarding justice...).
- Patient is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the GUIDEX® Versus Launcher™ Guiding Catheter in Adults' Patients With Coronary Artery Disease (CAD) Requiring Percutaneous Coronary Intervention (PCI): a Non-inferiority and Randomized, Clinical Trial.
The goal of this clinical trial is to compare two guiding catheters in patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic). The main question[s] it aims to answer are:
- Aren't the safety of medical devices inferior to each other?
- Aren't the efficacyof medical devices inferior to each other? Participants will be randomized (1:1) and have a percutaneous coronary interventionwith one of the two guiding catheters.
Read the detailed description
Cardiovascular disease (CVD) remains the most common cause of death in the European region. In line with the Global Burden of Disease (GBD) estimates from 2001, 43% of all Cardio Vascular Disease (CVD) deaths are related to coronary artery disease (CAD).
Treatment of CAD is always based on medication, which may also be supplemented by invasive procedures. The most significant historical advances in the treatment of coronary artery disease were the development of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI).
An essential element in the success of an angioplasty and in shortening the procedure, the guiding catheter is not simply a support. While, it's primary role is designed to provide a pathway through which balloon dilation catheter, guide wire or other devices are introduced, it can also contribute to significant semantic information since it is the first tool to appear in the field of view. A variety of guiding catheter references are available on the market.
Guiding catheters of various sizes and shapes are selected based on vessel anatomy, lesion characteristics, vascular access and procedural complexity.
The GUIDEX® device is a guiding catheter designed to be used in percutaneous coronary intervention. GUIDEX® device is on the Chinese market since September 2015 (certificate renewal in 2020) and is presented for CE marking according to MDR 2017/745.
The aim of the study is to assess the essential requirements for CE marking of Guidex®: the efficacy and safety of the device. Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic).
- Conditions
- Coronary Artery Disease
- Being tested
- GUIDEX® guiding catheter, Launcher™ coronary guide catheter
- Keywords
- Percutaneous coronary intervention, Guiding catheter
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIDEX® guiding catheterDevice
The main steps of the procedure Percutaneous Coronary Intervention are :
- The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.
- The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.
- The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.
- The catheter should should address the selected vascular site
- The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.
Launcher™ coronary guide catheterDevice
The main steps of the procedure Percutaneous Coronary Intervention are :
- The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.
- The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.
- The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.
- The catheter should should address the selected vascular site
- The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention with Guiding Catheter GUIDEX | Experimental | Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter Receives: Device: GUIDEX® guiding catheter |
| Percutaneous Coronary Intervention with Guiding Catheter Medtronics | Experimental | Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter Receives: Device: Launcher™ coronary guide catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE)
Analyze the frequency of major adverse cardiac events (MACE) during the procedure. MACE was defined as the following:
- Cardiac death
- Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
- TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Measured: Baseline until the end of the procedure
Secondary outcomes (7)
Percentage of subjects achieving angiographic with sucess
The percentage of subjects achieving angiographic success were defined as success in facilating delivery of the balloon dilation catheter, guidewire or other devices introduced in the coronary arteries, using the medical devices with <50% residual stenosis without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F - To confirm ), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Measured: Baseline until End of the procedure
Time used for the procedure (in minutes) .
Time (in minutes) between the start of the procedure until the end of the procedure
Measured: Baseline until end of the procedure (Day 1)
Frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following: a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Analyze the frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following:
- Cardiac death
- Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
- TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Measured: Baseline until discharge from the hospital (Day 2)
Incidence of complication and adverse event rates
Incidence of adverse event during 1 month after the PCI (in particular related to the potential adverse event at the puncture site).
Measured: [Time frame; to the baseline up to 30 days after the procedure)
Frequency of access-site-related complications.
The frequency of access-site related complications is defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery), which were considered to be major if they were associated with a vascular repair or a blood transfusion.
Measured: Baseline until End of the procedure
Ability to achieve co-axial engagement (in degrees)
Analyse the level of angulation of the coronary artery (in degrees) during the PCI
Measured: Baseline until end of the procedure (Day 1)
Assessed as Fluoroscopy time (in sec)
Assessed as fluoroscopy time (in sec) during the PCI
Measured: Baseline until end of the procedure (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start10 Apr 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Demax Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009757
- Sponsor's protocol ID
- CLI-00910
- Acronym
- GUIDEX®_FR
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Nothing
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the GUIDEX® Versus Launcher™ Guiding Catheter in Adults' Patients With Coronary Artery Disease (CAD) Requiring Percutaneous Coronary Intervention (PCI): a Non-inferiority and Randomized, Clinical Trial.
- ClinicalTrials.gov ID
- NCT06009757
- Acronym / sponsor ID
- GUIDEX®_FR / CLI-00910
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Guiding catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tianjin Demax Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare two guiding catheters in patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic). The main question[s] it aims to answer are:
- Aren't the safety of medical devices inferior to each other?
- Aren't the efficacyof medical devices inferior to each other? Participants will be randomized (1:1) and have a percutaneous coronary interventionwith one of the two guiding catheters.
Detailed description
Cardiovascular disease (CVD) remains the most common cause of death in the European region. In line with the Global Burden of Disease (GBD) estimates from 2001, 43% of all Cardio Vascular Disease (CVD) deaths are related to coronary artery disease (CAD).
Treatment of CAD is always based on medication, which may also be supplemented by invasive procedures. The most significant historical advances in the treatment of coronary artery disease were the development of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI).
An essential element in the success of an angioplasty and in shortening the procedure, the guiding catheter is not simply a support. While, it's primary role is designed to provide a pathway through which balloon dilation catheter, guide wire or other devices are introduced, it can also contribute to significant semantic information since it is the first tool to appear in the field of view. A variety of guiding catheter references are available on the market.
Guiding catheters of various sizes and shapes are selected based on vessel anatomy, lesion characteristics, vascular access and procedural complexity.
The GUIDEX® device is a guiding catheter designed to be used in percutaneous coronary intervention. GUIDEX® device is on the Chinese market since September 2015 (certificate renewal in 2020) and is presented for CE marking according to MDR 2017/745.
The aim of the study is to assess the essential requirements for CE marking of Guidex®: the efficacy and safety of the device. Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic).
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention with Guiding Catheter GUIDEX | Experimental | Device: GUIDEX® guiding catheterPatients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter |
| Percutaneous Coronary Intervention with Guiding Catheter Medtronics | Experimental | Device: Launcher™ coronary guide catheterPatients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients need to be at least 18 years old.
- Patients with significant coronary artery disease who qualify for PCI (according to ACC/AHA/SCAI 2021 guidelines, including that the patient has received medical therapy with exercise and dietary recommendations before or at the same time as the PCI decision and that the clinical decision depends on the cardiology team) and who can be treated with a radial and femoral approach
- Patients scheduled for for Percutaneous Coronary Intervention and must remain overnight for observation
- The target vessel must have a TIMI flow 3 at baseline
- Palpable radial or fermoral artery
Key exclusion criteria (16 listed)
- Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography)
- Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- Prior PCI procedure within the last 30 days of the index procedure
- Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
- Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUIDEX® guiding catheterThe main steps of the procedure Percutaneous Coronary Intervention are : * The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered. * The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques. * The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique. * The catheter should should address the selected vascular site * The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI. | Device | Percutaneous Coronary Intervention with Guiding Catheter GUIDEX |
| Launcher™ coronary guide catheterThe main steps of the procedure Percutaneous Coronary Intervention are : * The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered. * The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques. * The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique. * The catheter should should address the selected vascular site * The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI. | Device | Percutaneous Coronary Intervention with Guiding Catheter Medtronics |
Primary outcome
The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE)
Time frame: Baseline until the end of the procedure
Analyze the frequency of major adverse cardiac events (MACE) during the procedure. MACE was defined as the following: * Cardiac death * Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
7 secondary outcomes
Percentage of subjects achieving angiographic with sucess
Time frame: Baseline until End of the procedure
Time used for the procedure (in minutes) .
Time frame: Baseline until end of the procedure (Day 1)
Frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following: a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Time frame: Baseline until discharge from the hospital (Day 2)
Incidence of complication and adverse event rates
Time frame: [Time frame; to the baseline up to 30 days after the procedure)
Frequency of access-site-related complications.
Time frame: Baseline until End of the procedure
Ability to achieve co-axial engagement (in degrees)
Time frame: Baseline until end of the procedure (Day 1)
Assessed as Fluoroscopy time (in sec)
Time frame: Baseline until end of the procedure (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Nothing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUIDEX® guiding catheter and Launcher™ coronary guide catheter in people with Coronary Artery Disease, run by Tianjin Demax Medical Technology Co., Ltd at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE) (time frame: Baseline until the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.